MAUDE Adverse Event Report: PFM MEDICAL AG NIT-OCCLUD PDA; PDA OCCLUDER

Model Number	145096V2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Embolism (1829); Foreign Body In Patient (2687)
Date of Event	12/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) has been reviewed and showed no deviations.Thus, the nit-occlud system meets our specifications.This also shows that the procedure (positioning and releasing) was done without complications.The choice of the dimensioning of the occluder could have led to an anchorage with 1-2 turns on the pulmonary side which was not performed by the physician.There were no samples, film or image material available for a fault investigation.Only the description of the doctor was provided.In addition, the production documents have no deviations.Therefore, no qualified statement can be made by the manufacturer.The cause of the error cannot be determined.The physician stated that "it was a pda morphology issue." it is pointed out that the complained samples and if possible also film or picture material are necessarily made available in order to carry out a proper complaint processing.
Event or Problem Description
The nit-occlud was successfully implanted.After implantation, the physician waited and within 10 minutes, the product dislodged and migrated to the dao.Physician was able to snare the nit-occlud and retrieve it successfully, with no harm to the patient.Physician successfully implanted an amplatz duct occluder to complete the procedure.Physician was treating a type a pda.Patient age: (b)(6) yrs.Weight: (b)(6) kg.Measured ductus size (mm) - aortic: 9.3, pulmonary: 1.6, length 7.6.Procedure duration: 139 minutes.Pda access was both venous and aortal.A 6fr introducer sheath was used.Heparin (systemic): 1800 iu/kg.One flushing.It is unknown how many revolutions the physician moved the rotation screw.

• Brand Name: NIT-OCCLUD PDA
• Common Device Name: PDA OCCLUDER
• Manufacturer (Section D): PFM MEDICAL AG; wankelstrasse 60; köln, nordrhein-westfalen 50996 ; GM 50996
• MDR Report Key: 8308707
• Report Number: 2032582-2017-00011
• Device Sequence Number: 19158537
• Product Code: MAE
• UDI-Device Identifier: 04042301160010
• UDI-Public: 04042301160010
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P120009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2019
• Device Model Number: 145096V2
• Device Catalogue Number: 145096V2
• Device Lot Number: 1018865
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Weight: 13